The U.S. Food and Drug Administration has approved the first prescription drug treatment to boost low sexual desire in women.
The decision to approve the drug, called flibanserin, came late Tuesday after months of lobbying and debate over the drug's effectiveness and side effects. The drug's manufacturer, Sprout Pharmaceuticals, plans to market it under the brand name Addyi. It's expected to hit the market in mid-October.
"Today's approval provides women distressed by their low sexual desire with an approved treatment option," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement.
The FDA had rejected the drug twice before, in 2010 and 2013, but in June an FDA advisory panel voted to recommend approval on the condition that the drug's manufacturer develops a plan to limit safety risks. Flibanserin can cause low blood pressure, nausea, drowsiness and dizziness, especially when combined with alcohol.
The drug's label will carry a boxed warning - the most serious type - alerting doctors and patients that combining the pill with alcohol can cause dangerously low blood pressure and fainting. That same risk can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.
"This is not a drug you take an hour before you have sex. You have to take it for weeks and months in order to see any benefit at all," said Leonore Tiefer, a psychologist and sex therapist who organized a petition last month calling on the FDA to reject the drug.
Under a safety plan imposed by the FDA, doctors will only be able to prescribe Addyi after completing an online certification test demonstrating that they understand its side effects. Pharmacies will also have to be certified.
Sheri Mike is a married mother of two. After going on birth control in her late teens, she noticed a change in her sex drive.
"The lack of desire, the lack of sexual thoughts, no libido," she said. "It's just this one area that's kind of holding us back from being truly happy."
Now that the drug has been approved to treat low libido in premenopausal women, the 34-year-old is eager to see if it works for her.
"I've tried vitamins, me and my husband have tried counseling I've tried hypnotherapy, but none of those have worked," she said.
In clinical trials, women taking flibanserin reported between 0.5 and 1 additional sexually satisfying event per month than women taking placebo. They also reported higher levels of sexual desire, while scoring lower on measures of stress.
"These are very modest results," said Dr. Julia Heiman of the Kinsey Institute at Indiana University. "But on the other hand, even modest results can make a lot of difference when you're at a certain point in the clinical problem."
The drug is frequently referred to as "female Viagra," but in fact flibanserin is a completely different medication and does not work the same way in the body as drugs that increase blood flow to treat erectile dysfunction in men.
"This drug works centrally in the brain," CBS News medical contributor Dr. Tara Narula explained on "CBS This Morning." "It changes the norepinephrine, dopamine and serotonin levels. You take it every day and it takes a couple weeks to really reach peak effect. That's very different than Viagra, which changes the blood flow to the genital organs, you take it at the time of intercourse and the effects occur very rapidly."
Women and their doctors will have to decide whether the drug's modest benefits warrant taking a psychiatric pill on a daily basis.
Women with insurance can expect to pay between $30 and $75 per month for Addyi, depending on the terms of their coverage.
The FDA specifically approved the drug for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress.
Surveys estimate that 8 to 14 percent of women ages 20 to 49 have the condition, or about 5.5 to 8.6 million U.S. women. Because so many factors affect sexual appetite, there are a number of alternate causes doctors must rule out before diagnosing the condition, including relationship issues, medical problems, depression and mood disorders.
The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.